| Primary Device ID | D832SB0050 |
| NIH Device Record Key | d33055ab-3a2e-4282-a63b-ef857415e5d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plasdent |
| Version Model Number | SB-005 |
| Catalog Number | SB-005 |
| Company DUNS | 190377184 |
| Company Name | PLASDENT CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D832SB0050 [Primary] |
| NRD | Unit, Operative Dental, Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-27 |
| Device Publish Date | 2021-12-17 |
| D832SC90607X0 | Silicone Mouth Props, Small (Pedo), Orange |
| D832SC90603N0 | Silicone Mouth Props, Small (Pedo), Neon Yellow |
| D832SC90507X0 | Silicone Mouth Props, Medium (Child), Orange |
| D832SC90504T0 | Silicone Mouth Props, Medium (Child), Turquoise |
| D832SC90407X0 | Silicone Mouth Props, Large (Adult), Orange |
| D832SC904010X0 | Silicone Mouth Props, Large (Adult), Dark Purple |
| D832SC9030110 | Silicone Mouth Props, Extra Large Adult, Black |
| D832SC9020110 | Silicone Mouth Props, Edentulous, Black |
| D832RB906090 | Rubber Mouth Props, Small (Pedo), Dark Gray |
| D832RB905090 | Rubber Mouth Props, Medium (Child), Dark Gray |
| D832RB904090 | Rubber Mouth Props, Large (Adult), Dark Gray |
| D832EX90600 | Disposable Mouth Props, Small (Pedo), White |
| D832EX90500 | Disposable Mouth Props, Medium (Child), White |
| D832EX90400 | Disposable Mouth Props, Large (Adult), White |
| D832CRH20 | Cotton Roll Holders, Disposable, Blue |
| D832SB0080 | Jumbo Multi Steri Box, 2 Large & 4 Small Sections |
| D832SB0070 | Square Multi Steri Box, 2 Small Sections |
| D832SB0050 | Rectangular Steri Box, Capacity: 20 |
| D832SB0040 | Small Round Steri Box, Capacity: 6 |
| D832SB0030 | Large Round Steri Box, Capacity: 16 |
| D832SB0020 | Rectangular Multi Steri Box, 5 Large Sections |
| D832SB0010 | Square Multi Steri Box, 4 Small Sections |
| D832MA250 | Micro Aspirators - 25 Gauge, Blue |
| D832MA200 | Micro Aspirators - 20 Gauge, Yellow |
| D832MA180 | Micro Aspirators - 18 Gauge, Pink |
| D832MA010 | Micro Aspirators - Untipped, Clear |
| D832LLUT0 | 12cc Utility Plastic Syringe, Disposable |
| D832LL120 | 12cc Luer Lock Syringe, Plastic, Disposable |
| D832LL060 | 6cc Luer Lock Syringe, Plastic, Disposable |
| D832LL030 | 3cc Luer Lock Syringe, Plastic, Disposable |
| D832LL01B110 | Uncalibrated 1cc Syringe, Black, Luer-Lock |
| D832LL010 | 1cc Luer Lock Syringe, Calibrated, Disposable |
| D832JB0040 | Jumbo Box - Multi, Multi-Function |
| D832JB0030 | Jumbo Box - Burs & Endo, 70 Bur, 70 Endo, 4 Vials |
| D832JB0020 | Jumbo Box - Endo, 144 Endo Instruments |
| D832JB0010 | Jumbo Box - Burs, 160 FG Burs |
| D832EFIR20 | Round Endo Foam Inserts, Blue |
| D832EFI39X0 | Rectangular Endo Foam Insert, Dark Gray |
| D832EFI29X0 | Square Endo Foam Inserts, Dark Gray |
| D832EFI10 | Triangle Endo Foam Inserts, White |
| D832ED006MIX0 | Square Endo Box, 18 Endo, 18 Bur, 2 Vials |
| D832ED006GP0 | Square Endo Box, 6 Gutta Percha Vials |
| D832ED006FR0 | Square Endo Box, 36 Endo Instruments |
| D832ED005MIX0 | Rectangular Endo Box, 30 Endo, 30 bur, 4 Vials |
| D832ED005GP0 | Rectangular Endo Box, 18 Gutta Percha Vials |
| D832ED005FR0 | Rectangular Endo Box, 72 Endo Instruments |
| D832ED004MIX0 | Small Round Endo Box, 9 Endo, 9 Bur, 2 Vials |
| D832ED004GP0 | Small Round Endo Box, 4 Gutta Percha Vials |
| D832ED004FR0 | Small Round Endo Box, 26 Endo Instruments |
| D832ED003MIX0 | Large Round Endo Box, 15 Endo, 15 Bur, 4 Vials |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PLASDENT 88750471 not registered Live/Pending |
Shen, Chu 2020-01-08 |